Deferasirox Glenmark: detailed information

Package leaflet: Information for the user

Deferasirox Glenmark 90 mg film-coated tablets, 180 mg film-coated tablets, 360 mg film-coated tablets

deferasirox
Read this entire leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Deferasirox Glenmark is and what it is used for
What you need to know before taking Deferasirox Glenmark
How to take Deferasirox Glenmark
Possible side effects
How to store Deferasirox Glenmark
Contents of the pack and other information

1. What Deferasirox Glenmark is and what it is used for

What Deferasirox Glenmark is
Deferasirox Glenmark contains an active substance called deferasirox. It is an iron chelator, that is, a
medicine used to remove excess iron from the body (iron overload). Deferasirox binds excess iron and removes it, primarily through the faeces.

What Deferasirox Glenmark is used for
Patients with various forms of anaemia (e.g. thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)) may require repeated blood transfusions. However, these can lead to excess iron in the body. This occurs because blood contains iron, and the body lacks a natural way to eliminate excess iron introduced through blood transfusions. In patients with thalassaemia syndromes who are not receiving blood transfusions, iron overload may also develop over time, primarily due to increased dietary iron absorption in response to a low blood cell count. Over time, excess iron can damage vital organs such as the liver and heart. Medicines known as iron chelators are used to remove excess iron and reduce the risk of organ damage.

Deferasirox Glenmark is used to treat chronic iron overload due to frequent blood transfusions in patients with beta-thalassaemia major aged 6 years and older.

Deferasirox Glenmark is also used to treat chronic iron overload when therapy with deferoxamine is contraindicated or inadequate in patients with beta-thalassaemia major who have iron overload due to infrequent blood transfusions, in patients with other forms of anaemia, and in children aged between 2 and 5 years.

Deferasirox Glenmark is also used, when therapy with deferoxamine is contraindicated or inadequate, to treat patients aged 10 years and older who have iron overload associated with thalassaemia syndromes but who do not require blood transfusions.

2. What you should know before taking Deferasirox Glenmark

Do not take Deferasirox Glenmark

if you are allergic to deferasirox or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor before taking Deferasirox Glenmark. If you think you might be allergic, consult your doctor.
if you have moderate or severe kidney disease.
if you are currently taking any other iron chelating medicine.

Deferasirox Glenmark is not recommended

if you have advanced myelodysplastic syndrome (MDS: reduced blood cell production by the bone marrow) or advanced-stage cancer.

Warnings and precautions
Talk to your doctor or pharmacist before taking Deferasirox Glenmark:

if you have kidney or liver problems.
if you have heart problems due to iron overload.
if you notice a marked decrease in urine output (a sign of kidney problems).
if you develop a severe skin rash, or have difficulty breathing, dizziness, or swelling, particularly of the face and throat (signs of a severe allergic reaction, see also section 4 “Possible side effects”).
if you experience a combination of any of the following symptoms: skin rash, flushed skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of a severe skin reaction, see also section 4 “Possible side effects”).
if you experience a combination of drowsiness, pain in the upper right abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems).
if you experience difficulty thinking, remembering information, or solving problems, feel less alert or aware, or feel very drowsy with low energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems, see also section 4 “Possible side effects”).
if you vomit blood and/or have black stools.
if you experience frequent abdominal pain, especially after eating or after taking Deferasirox Glenmark.
if you have frequent heartburn.
if you have low platelet or white blood cell counts in blood tests.
if you have blurred vision.
if you have diarrhoea or vomiting. If any of these situations apply to you, inform your doctor immediately.

Monitoring during treatment with Deferasirox Glenmark
During treatment, you will have regular blood and urine tests. These tests will monitor the amount of iron in your body (blood ferritin levels) to assess how well Deferasirox Glenmark is working. The tests will also check kidney function (blood creatinine levels, presence of protein in urine) and liver function (blood transaminase levels). Your doctor may request a kidney biopsy if significant kidney damage is suspected. To determine the amount of iron in your liver, you may also undergo magnetic resonance imaging (MRI) scans. Your doctor will use these test results to determine the most appropriate dose of Deferasirox Glenmark for you and to decide when treatment should be stopped.
As a precautionary measure, your vision and hearing will be examined annually during treatment.

Other medicines and Deferasirox Glenmark
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important for:

other iron chelators, which must not be taken with Deferasirox Glenmark,
antacids (medicines used to treat heartburn) containing aluminium, which must not be taken at the same time of day as Deferasirox Glenmark,
ciclosporin (used to prevent organ transplant rejection or for other conditions such as rheumatoid arthritis or atopic dermatitis),
simvastatin (used to lower cholesterol),
certain painkillers or anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids),
oral bisphosphonates (used to treat osteoporosis),
anticoagulant medicines (used to prevent or treat blood clotting),
hormonal contraceptives (birth control medicines),
bepridil, ergotamine (used for heart conditions and migraines),
repaglinide (used to treat diabetes),
rifampicin (used to treat tuberculosis),
phenytoin, phenobarbital, carbamazepine (used to treat epilepsy),
ritonavir (used to treat HIV infection),
paclitaxel (used in cancer treatment),
theophylline (used to treat respiratory diseases such as asthma),
clozapine (used to treat psychiatric disorders such as schizophrenia),
tizanidine (used as a muscle relaxant),
colestyramine (used to reduce blood cholesterol levels),
busulfan (used as pre-transplant treatment to destroy the original bone marrow before transplantation),
midazolam (used to relieve anxiety and/or sleep disorders).

Additional monitoring may be required to check blood levels of some of these medicines.

Elderly patients (aged 65 years and older)
Deferasirox Glenmark can be used in patients aged 65 years and older at the same dose as in adults. Elderly patients may experience more side effects (particularly diarrhoea) than younger patients. They should be closely monitored by their doctor for side effects, which may require dose adjustment.

Children and adolescents
Deferasirox Glenmark can be used in children and adolescents aged 2 years and older who receive regular blood transfusions, and in children and adolescents aged 10 years and older who do not receive regular blood transfusions. The doctor will adjust the dose according to the patient's growth.
Deferasirox Glenmark is not recommended for children under 2 years of age.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Deferasirox Glenmark is not recommended during pregnancy unless strictly necessary.
If you are currently using a hormonal contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. a condom), as Deferasirox Glenmark may reduce the effectiveness of hormonal contraceptives.
Breastfeeding is not recommended during treatment with Deferasirox Glenmark.

Driving and using machines
If you feel dizzy after taking Deferasirox Glenmark, do not drive or operate tools or machinery until you feel well again.

Deferasirox Glenmark contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Deferasirox Glenmark

Treatment with Deferasirox Glenmark will be monitored by a doctor experienced in managing iron overload due to blood transfusions.
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.

How much Deferasirox Glenmark to take

The dose of Deferasirox Glenmark is based on body weight for all patients. Your doctor will calculate the dose you need and tell you how many tablets to take each day.

The usual starting daily dose of Deferasirox Glenmark film-coated tablets for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower initial dose depending on your individual treatment needs.
The usual starting daily dose of Deferasirox Glenmark film-coated tablets for patients not receiving regular blood transfusions is 7 mg per kilogram of body weight.
Depending on your response to treatment, your doctor may later adjust your dose, either increasing or decreasing it.
The maximum recommended daily dose of Deferasirox Glenmark film-coated tablets is:
- 28 mg per kilogram of body weight for patients receiving regular blood transfusions,
- 14 mg per kilogram of body weight for adults not receiving regular blood transfusions,
- 7 mg per kilogram of body weight for children and adolescents not receiving regular blood transfusions.

In some countries, deferasirox may also be available as dispersible tablets produced by other manufacturers. If you switch from such dispersible tablets to Deferasirox Glenmark film-coated tablets, your dose will change. Your doctor will calculate the dose you require and inform you how many film-coated tablets to take each day.

When to take Deferasirox Glenmark

Take Deferasirox Glenmark once daily, every day, at approximately the same time each day, with a glass of water.
Take Deferasirox Glenmark film-coated tablets on an empty stomach or with a light meal. Taking Deferasirox Glenmark at the same time each day will also help you remember when to take your tablets.

For patients unable to swallow the tablets whole, Deferasirox Glenmark film-coated tablets may be crushed and administered by mixing the full dose with soft food such as yoghurt or applesauce (apple puree). The food should be consumed immediately and completely. Do not store it for later use.

How long to take Deferasirox Glenmark

Continue taking Deferasirox Glenmark every day for the duration prescribed by your doctor. This is a long-term treatment, which may last for months or years. Your doctor will monitor your condition regularly to ensure the treatment is effective (see also section 2: "Monitoring of treatment with Deferasirox Glenmark").
If you have any questions about how long to take Deferasirox Glenmark, speak with your doctor.

If you take more Deferasirox Glenmark than you should

If you have taken too much Deferasirox Glenmark or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately for advice. Show the doctor the tablet packaging. Urgent medical treatment may be necessary. Symptoms may include abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which may be serious.

If you forget to take Deferasirox Glenmark

If you forget to take a dose, take it as soon as you remember on the same day. Take the next dose at your usual time. Do not take a double dose the next day to make up for the missed tablet(s).

If you stop taking Deferasirox Glenmark

Do not stop taking Deferasirox Glenmark unless instructed by your doctor. If you stop taking it, excess iron will no longer be removed from your body (see also above section "How long to take Deferasirox Glenmark").

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate in intensity and usually disappear after a period of treatment ranging from a few days to a few weeks.
Some side effects may be serious and require immediate medical attention.
These side effects are uncommon (may affect up to 1 in 100 people) or rare
(may affect up to 1 in 1,000 people).

If you develop a severe skin rash, or have difficulty breathing and dizziness or swelling, mainly of the face and throat (signs of a severe allergic reaction),
If you develop a combination of any of the following symptoms: skin rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of severe skin reactions),
If you notice a marked reduction in urine output (sign of kidney problem),
If you experience a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems),
If you experience difficulty thinking, remembering information, or solving problems, if you feel less alert or aware, or feel very drowsy with little energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems and may lead to changes in brain function),
If you vomit blood and/or have black stools,
If you experience frequent abdominal pain, particularly after eating or taking Deferasirox Glenmark,
If you experience frequent heartburn,
If you experience partial loss of vision,
If you experience severe pain in the upper part of the abdomen (pancreatitis), stop taking this medicine and contact your doctor immediately. Some side effects may become serious. These side effects are uncommon.
If you have blurred or cloudy vision,
If you experience hearing loss, contact your doctor as soon as possible. Other side effects Very common (may affect more than 1 in 10 people)
Abnormal kidney function tests.

Common (may affect up to 1 in 10 people)

Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, abdominal pain, bloated stomach, constipation, indigestion
Skin rash
Headache
Abnormal liver function tests
Itching
Abnormal urine test (protein in urine) If any of these effects becomes severe, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

Dizziness
Fever
Sore throat
Swelling of the arms or legs
Change in skin colour
Anxiety
Sleep disorders
Tiredness If any of these effects becomes severe, inform your doctor.

Frequency not known (frequency cannot be estimated from the available data).

A reduction in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (worsening of anaemia), in the number of white blood cells (neutropenia), or in the number of all types of blood cells (pancytopenia)
Hair loss
Kidney stones
Low urine production
Tear in the wall of the stomach or intestine, which may be painful and cause nausea
Severe pain in the upper part of the abdomen (pancreatitis)
Increased acidity of the blood (metabolic acidosis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deferasirox Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
Do not use the pack if it is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Deferasirox Glenmark contains
The active substance is deferasirox.

Each film-coated tablet of Deferasirox Glenmark 90 mg contains deferasirox 90 mg.
Each film-coated tablet of Deferasirox Glenmark 180 mg contains deferasirox 180 mg.
Each film-coated tablet of Deferasirox Glenmark 360 mg contains deferasirox 360 mg.

The other components are microcrystalline cellulose; crospovidone; anhydrous colloidal silica; poloxamer;
povidone; sodium starch glycolate; magnesium stearate and isopropyl alcohol. The tablet coating
contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; aluminium lake containing
indigo carmine (E132).

Description of the appearance of Deferasirox Glenmark and contents of the pack
Deferasirox Glenmark is supplied as film-coated tablets.

Deferasirox Glenmark 90 mg film-coated tablets are light blue, oval, biconvex film-coated tablets with bevelled edges, marked with "L" on one side and "663" on the other.
Deferasirox Glenmark 180 mg film-coated tablets are medium blue, oval, biconvex film-coated tablets with bevelled edges, marked with "L" on one side and "664" on the other.
Deferasirox Glenmark 360 mg film-coated tablets are dark blue, oval, biconvex film-coated tablets with bevelled edges, marked with "L" on one side and "665" on the other.

Blister pack:
Each pack contains 30 or 90 film-coated tablets.
Bottle pack:
Each bottle contains 30 film-coated tablets.
Bulk pack:
Each bottle contains 1,000 film-coated tablets.
Not all pack sizes or strengths may be marketed in your country.

Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestrasse 31, Groebenzell, 82194
Munich, Germany

Manufacturer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
Paola
PLA 3000
Malta
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
Vysoke Myto
566 01
Czech Republic

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Denmark: Deferasirox Glenmark
Czech Republic: Deferasirox Glenmark
Germany: Deferasirox Glenmark 90 mg Filmtabletten
Deferasirox Glenmark 180 mg Filmtabletten
Deferasirox Glenmark 360 mg Filmtabletten
Spain: Deferasirox Viso Farmacéutica 90 mg
comprimidos recubiertos con película EFG
Deferasirox Viso Farmacéutica 360 mg
comprimidos recubiertos con película EFG
Finland: Deferasirox Glenmark 90 mg tabletti, kalvopäällysteinen
Deferasirox Glenmark 180 mg tabletti, kalvopäällysteinen
Deferasirox Glenmark 360 mg tabletti, kalvopäällysteinen
Sweden: Deferasirox Glenmark 90 mg filmdragerad tablet
Deferasirox Glenmark 180 mg filmdragerad tablet
Deferasirox Glenmark 360 mg filmdragerad tablett
Slovakia: Deferasirox Glenmark 180 mg filmom obalené tablety
Deferasirox Glenmark 360 mg filmom obalené tablety
Italy: Deferasirox Glenmark